AccessGUDID - DEVICE: ORC-A, F/G ASSY, RANFAC, 20 GA (M9796808501M0)

GUDID

Device Identifier (DI) Information

Brand Name: ORC-A, F/G ASSY, RANFAC, 20 GA
Version or Model: 20 GAUGE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ORC-A-20
Company Name: RANFAC CORP.

Primary DI Number: M9796808501M0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121622872 *Terms of Use

Device Description: ORC-A, F/G ASSY, RANFAC, 20 GA PN 68085-01M

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41976	Rigid endoscopic cannula, single-use	A sterile, rigid, single-lumen device intended to be used during endoscopy to provide cannulation for the instillation or aspiration of fluid to/from a targeted area of the body (e.g., introduction of drug solutions, a contrast medium or other kinds of fluid/solution into a body cavity for diagnosis and treatment) or for the introduction/accommodation of another device. It will typically be made of high-grade stainless steel and/or other durable materials. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GBZ	Catheter, Cholangiography

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 20 Gauge

Device Record Status

Public Device Record Key: c28af773-17ef-4d14-ab6b-a2b27ed944ae
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 04, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M9796808501M9	20	M9796808501M1		In Commercial Distribution	Case
M9796808501M1	10	M9796808501M0		In Commercial Distribution	Inner Pack

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 5085884400
Email: info@ranfac.com

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